with drawings, photographs, written and verbal descriptions of the operation and other alternative surgeries including Open Roux-en-Y Gastric Bypass,

Transcription

1 Operative Treatment Consent Agreement: The purpose of this legal document is to confirm in the presence of witnesses your informed request that you wish to proceed with Mini-Gastric Bypass for obesity. You are asked to please read this document very carefully! As you read each paragraph, you are encouraged to discuss any questions about it with your surgeon. If you agree with everything in each paragraph as you read it you are asked to: Write your initials next to each paragraph Check the Box next to each paragraph Write at least two sentences or more describing the paragraph and showing your understanding of what you have read. Preoperative Information and Education My initials and comments in this form are meant to demonstrate that I understand and completely agree that I have been given extensive preoperative education and information about obesity, the risks of obesity and the risks and possible benefits of the surgical procedures in general and the Mini-Gastric Bypass in particular. I understand that this consent form is designed to provide a written confirmation of these discussions with my surgeon and The California Center for Laparoscopic Obesity Surgery support staff and the extensive educational process that I have participated in by repeating and recording some of the more significant medical information given to me. I understand that this effort of this long document purposefully intended to make me think over my decision to have surgery once again. I confirm that my family, my Doctor and I have extensively reviewed the decision to proceed with this weight loss surgery. This document is a written record of my efforts to be well informed about my decision to proceed with operation. I can confirm that I wish to consent to go forward with the proposed Mini-Gastric Bypass procedure. Write a Description of the Previous Paragraph and Comments (More than 2 sentences My Condition/Diagnosis: I recognize that I am overweight. I understand that obesity has been shown to be dangerous, unhealthy and increase my risk of death from a variety of medical illnesses. I affirm that I understand that some scientific studies conclude that obesity places individuals at increased risk of disability, respiratory disease, high blood pressure, heart disease, high cholesterol, stroke, diabetes, arthritis, clotting problems, cancer and death as well as other serious and less serious medical illnesses. I clearly and completely understand these issues from my own experience, my discussions with my family my discussions with my doctor and from the very extensive reading and discussions with patients of CaCLOS and my surgeon. From this careful and calculated investigation, I believe strongly that I should be considered for surgery to help me lose weight. If you agree that, everything in the above paragraph is correct, check Yes Write a Description of the Previous Paragraph and Comments (More than two sentences): Proposed Procedure: The Mini-Gastric Bypass: I understand that the procedure that my surgeon has recommended for the treatment my obesity is the Mini-Gastric Bypass. My surgeon with the help and assistance of the staff of The California Center for Laparoscopic Obesity Surgery, my doctor, my family and many patients that have undergone Mini-Gastric Bypass have provided me with a detailed explanation of the medical history of the development of the surgical treatment of obesity, gastric surgery as a treatment of obesity, the development of laparoscopic (minimally invasive) surgery and the Mini-Gastric Bypass. I have been provided

2 with drawings, photographs, written and verbal descriptions of the operation and other alternative surgeries including Open Roux-en-Y Gastric Bypass, Laparoscopic Roux-en-Y Gastric Bypass, Slapstick Ring Vertical Gastric Bypass (Fobi Pouch), Micro pouch Gastric Bypass, Antecolic Laparoscopic Roux-en-Y Gastric Bypass, Long Limb Gastric Bypass, Biliopancreatic Diversion, Biliopancreatic Diversion with Duodenal Switch, Gastric Band, Laparoscopic Gastric Band, Laparoscopic Adjustable Gastric Band, Vertical Banded Gastroplasty, Laparoscopic Vertical Banded Gastroplasty and Others. I have been allowed to talk with patients that have previously undergone the Mini-Gastric Bypass surgery. I have been very strongly encouraged to make every reasonable effort to investigate and understand the details of the operation. I believe that my surgeon and the staff of CaCLOS have gone beyond what many other doctors do to inform me of the risks and benefits of the surgery and to assist me in making a good decision about obesity and surgery for obesity. If you agree that, everything in the above paragraph is correct, check Yes Write a Description of the Previous Paragraph and Comments (More than two sentences): Controversy in Medicine/Disagreements over the Surgical Treatment of Obesity I affirm here unequivocally and without reservations that I understand that medical care often faces major controversy. I clearly recognize that Weight Loss Surgery now is filled with controversy: gastric banding types of surgery vs. bypass types of surgery, proximal gastric bypasses vs. distal gastric bypasses, bypass type surgery vs. the duodenal switch vs. the Fobi pouch and the new Adjustable Gastric Band. The list goes of disagreements about whether to have surgery and what kind of surgery is best is extensive. I understand that there are many different types and variations in the surgical procedures being performed for weight loss in America and around the world at this time. I also know that although many studies document the value of surgery for obesity, there remain many physicians and surgeons who are opposed to the idea of any form of surgical treatment of obesity. I know that because of the numerous problems and complications that can occur with weight loss surgery many physicians and surgeons prefer to avoid bariatric surgery entirely[1]. I clearly realize that there are a variety of different Types of Weight Loss Surgery, some of which are shown in the table below. Table 1: Different Types of Weight Loss Surgery Types of Weight Loss Surgery Open Roux-en-Y Gastric Bypass Laparoscopic Roux-en-Y Gastric Bypass Silastic Ring Vertical Gastric Bypass (Fobi Pouch) Micro pouch Gastric Bypass Antecolic Laparoscopic Roux-en-Y Gastric Bypass Long Limb Gastric Bypass Biliopancreatic Diversion Biliopancreatic Diversion with Duodenal Switch Gastric Band Laparoscopic Gastric Band Laparoscopic Adjustable Gastric Band Vertical Banded Gastroplasty Laparoscopic Vertical Banded Gastroplasty Others I understand that it is my surgeon s feeling that no one of these surgical choices is necessarily bad, but I recognize that each type of surgery has its own associated risks and complications. Their risk and complications have kept all of them from being universally adopted. It demonstrates that surgery for obesity has not yet reached a perfect surgical solution. The number and the great variety of the different types of surgery offered for the treatment of obesity and the acrimony and disagreement between practitioners over the selection of the surgical technique suggests that there are opportunities for further improvement of the presently available weight loss surgery. It means that continued assessment of innovations in surgical procedures is appropriate. I have spent significant time and effort evaluating this question and I believe that the presently available operations for the treatment of obesity can and should be offered to obese individuals. I feel that the need for treatment of obesity is great and that

3 all of the medical, drug and surgical solutions that we have at present are imperfect. I know that I could have chosen any one of these other types of surgical procedures but after a slow careful and detailed investigation, I have decided to have the Mini-Gastric Bypass. I know that the Mini-Gastric Bypass is not perfect, I know that I feel certain risks and complications that can occur, but after reviewing all of the information, I feel comfortable that my family, my doctor and I agree that the Mini-Gastric Bypass is the best choice for me. The "Old Loop" Gastric Bypass I know that some critics of the Mini-Gastric Bypass have compared it to the "Old Loop" Gastric Bypass. The following figures and discussion explain the differences between the Mini-Gastric Bypass, the Standard Billroth II and the "Old Loop Gastric Bypass. Billroth II Gastrojejunostomy The Billroth II is the most commonly performed type of connection between the stomach and the small bowel. By a margin of 4 to 1, the Billroth II is preferred over the Roux-en-Y when general surgeons choose to connect the stomach to the bowel. The Billroth II is a surgical procedure used routinely in the treatment of trauma, stomach cancer and peptic ulcers. Every year over 16,000, Billroth II surgeries are performed in America alone. In the usual Billroth II, the esophagus and the body of the stomach are distant from the Billroth II connection. The Billroth II connects the stomach to the jejunum, the upper-middle portion of the small intestine. Like the Mini-Gastric Bypass, the standard Billroth II places the connection between the stomach and the small bowel low on the stomach at the junction between the body and the antrum of the stomach. The lower part of the stomach that is often removed in the usual Billroth II surgery. Figure 1: Standard Billroth II Gastrojejunostomy. I know that the Mini-Gastric Bypass is a form of gastric bypass that uses the Billroth II type of connection. I know that some surgeons and other doctors do not like the Billroth II type of connection. I am aware of this and want to go ahead. I have weighed the risks and benefits of the surgical techniques used in the MGB and I favor the Billroth II type connection used in the MGB. If you agree that, everything in the above paragraph is correct, check Yes Write a Description of the Previous Paragraph and Comments (More than two sentences): The "Old Loop" Billroth II Gastrojejunostomy I know that there was an "Old Loop" Gastric Bypass included a small high stomach pouch that was placed high up on the stomach next to the esophagus. The loop that carries bile was placed close to the esophagus and this led to the associated problems with esophagitis that occurred in some surgeon s experience with the old loop type gastric bypass. This configuration is in many ways much like the common general surgical procedure called a total gastrectomy. It is widely agreed that a total gastrectomy is not a good choice for a Billroth II reconstruction. This old loop is different from the Mini-Gastric Bypass. The Old Loop created a stomach pouch that was also based upon the outside edge of the stomach. This kind of pouch commonly stretches leading to failure of weight loss. Figure 2: "Old Loop" Gastric Bypass I know that there are many surgeons and doctors that feel that the old loop gastric bypass and the Mini-Gastric

4 Bypass are similar and since the Old Loop did not work well then the Mini-Gastric Bypass will also do poorly. I have investigated the Mini-Gastric Bypass in detail, I know the difference between the old loop and the MGB and I want to go ahead and have the MGB. If you agree that, everything in the above paragraph is correct, check Yes Write a Description of the Previous Paragraph and Comments (More than two sentences): The Mini-Gastric Bypass The Mini-Gastric Bypass does have a Billroth II type loop connection like the old loop" bypass, but the loop in the Mini-Gastric Bypass is placed low on the stomach far away from the esophagus. This is in the same position as the loop in the standard Billroth II done for ulcers and other diseases. The Mini-Gastric Bypass creates a long narrow gastric tube that places the connection of the stomach and the bowel low in the stomach and keeps the stream of bile away from the esophagus. The other advantages are that the surgery is easily accessible in the event that the surgery needs to be revised. Figure 3: Mini-Gastric Bypass I know that there are many surgeons and doctors that feel that the old loop gastric bypass and the Mini-Gastric Bypass are similar and since the Old Loop did not work well then the Mini-Gastric Bypass will also do poorly. I have investigated the Mini-Gastric Bypass in detail, I know the difference between the old loop and the MGB and I want to go ahead and have the MGB. If you agree that, everything in the above paragraph is correct, check Yes Write a Description of the Previous Paragraph and Comments (More than two sentences): Previous Mini-Gastric Bypass Results: I understand that at the present time over 6,000 total Mini-Gastric Bypass operations have been performed by Dr. Rutledge and tens of thousands of MGB operations have been performed around the world. I understand that the overall complication rate in the Mini-Gastric Bypass patients at this time is approximately 5%. I know that three of Dr. Rutledge s patients died in the first month following surgery giving an overall 30-day mortality rate of 0.05%. I know that the overall average hospital stay for Mini-Gastric Bypass Patients to date has been 1.1 days. I know that I will probably be discharged from the hospital today or tomorrow, the day after my surgery. I am ready for this and have arranged for travel from the hospital and for care at home. If you agree that, everything in the above paragraph is correct, check Yes Write a Description of the Previous Paragraph and Comments (More than two sentences): Risks/Benefits of Proposed Procedure:

5 Just as there may be some expected benefits from the Mini-Gastric Bypass procedure proposed in my case, I also understand that all medical and surgical procedures, including the Mini-Gastric Bypass involve risks. I have been told and I understand that my obesity increases my risks of these problems and complications. These risks include: Complications Description Allergic Reactions All kinds of allergic drug and chemical reactions are possible from my treatment, from minor reactions such as a rash to sudden overwhelming reactions that can cause death. Anesthetic Complications I know and consent to the fact that general Anesthesia will be used to put me to sleep for the operation. I am aware that the anesthesia has major and minor risks can be associated with a variety of different complications up to and including death. Feeling Sick, Some operations, anesthetics and pain-relieving drugs are more likely to Nausea And cause sickness (nausea) than others. Sickness can often be treated with Vomiting anti-vomiting drugs (anti-emetics), but it may last from a few hours to several days. Sore Throat You will have a tube in your airway to breathe for you and it may give you a sore throat. The discomfort or pain lasts from a few hours to days. Dizziness, Blurred Your anesthetic or loss of fluids may lower your blood pressure and make Vision: you feel faint. Shivering This may be due to you getting cold during the surgery, to some drugs, or to stress. Headache This may be due to the effects of the anesthetic, to the surgery, to lack of fluids, or to anxiety. More severe headaches may occur after a spinal or epidural anesthetic. Bleeding Blood Clots Infection Leak Surgery involves incisions and cutting that can result in bleeding complications, from minor to massive, that can lead to the need for emergency surgery, transfusion or death. In addition, called Deep Vein Thrombosis (DVT) and Pulmonary Embolus can sometimes cause death. In the 3,000, people that have had the Mini-Gastric Bypass 0.01% have developed clots in their legs (Deep Vein Thrombosis) and 0.03% have had a pulmonary embolus. This is lower than seen in other series of gastric bypass surgery, but it can still happen. I understand that I need to get out of bed the evening after surgery, move, and flex my feet and legs to try to help prevent clots from forming in my legs. I also know that although other surgeons routinely use blood thinners to prevent clots that they can cause bleeding complications and are not used by my surgeon for the Mini-Gastric Bypass. Including wound infections, bladder infections, pneumonia, skin infections and deep abdominal infections that can sometimes lead to death. I know that after weight loss operations on the stomach the new connections can leak. The leak can allow stomach acid, bacteria and digestive enzymes to escape into the abdomen causing a severe and potentially lethal infection and or abscess. I am aware that the surgical complication most commonly related to an increased morbidity and mortality is a suture line leak. I am well aware that this is a technically demanding operation and that a leak rate of 2 to 5% for gastric bypass surgeries and 0.5% for banding procedures is frequently reported. I know that if a leak is suspected, patients may need to undergo x-ray testing or emergency surgery. I am aware that emergency surgery may needed that multiple drains may need to be placed. I know that patients with a leak may also need to be in the intensive care unit for an extended

6 Narrowing (stricture) Indigestion, Acid/Bile Reflux or Ulcers Ulcers Post-gastrectomy (Stomach Removal) Problems Bile Reflux Gastritis period of time, sometime weeks or months, and I and my family clearly understand that the complication can be lethal. In the series of over 6,000 patients treated by Dr. Rutledge and CaCLOS there have 39 leaks, a 0.65% leak rate. This is similar to or less than the reported national results. Narrowing (stricture), inflammation and/or ulceration of the connection between the stomach and the small bowel can occur after the operation this can require emergency operation, intensive care and can sometimes lead to death. To protect your new stomach from ulcers you must never again take aspirin, or aspirin like drugs such as Motrin, Ibuprofen, Naproxen, Relafen or other similar drugs. The operation can sometimes lead to severe nausea, vomiting, indigestion, abdominal pain, gastritis or ulcers. This can be severe and can last for days, weeks and possibly even longer. This is especially likely if you have had previous problems with nausea, abdominal pain or ulcers. Nausea is much more common in women than men. Women that have been treated with any type of hormone therapy (Premarin, Estrogen or Birth Control Pills) are much more likely to have nausea and vomiting after surgery. Chronic gastritis has been found in many patients years after the Billroth II. Biliary duodeno-gastro-esophageal reflux can be injurious on the mucosa of the stomach and the esophagus. Bile reflux if it occurs and causes problems the operation can be revised. In most cases, revision is not necessary. I know that I may develop an ulcer after surgery. I know I need to avoid ulcer causing foods, habits and medications. I know in some cases the ulcer may require surgery or reversal of my surgery. Studies of patients that have had partial removal of their stomach (Post gastrectomy) can have a variety of different complications. In one study ulcers occurred in 2% of patients, Diarrhea (16%), Dumping (14%), Bilious vomiting (10%), Iron deficiency anemia (12%), B12 deficiency (14%) and Folate deficiency (32%). Numerous problems can follow stomach removal surgery. These post-gastrectomy problems may occur early after surgery or many months or years later. The early problems relate to the surgery itself. There are many late post-gastrectomy syndromes; these may be more disabling than the dyspeptic symptoms that led to the surgery in the first place. Complications of gastric surgery: Esophagus; Gastroesophageal reflux, Dysphagia Stomach; Delayed gastric emptying, Bezoars, Outlet obstruction, Stomatitis, Recurrent ulcers, Stump carcinoma, Afferent loop syndrome, Small intestine Diarrhea, Dumping syndrome, Bacterial contamination syndrome, Unmasked celiac disease, unmasked pancreatic insufficiency or unmasked lactase deficiency, weight loss and malabsorbtion, (Iron, Folate, Vitamin B12, Thiamine (vitamin B1), Calcium, Fats, and Anemia.) Gallbladder Cholelithiasis Reflux of bile acids into the esophagus may contribute to injury of the esophageal lining. Bile is a component of digestive juices normally present in the small intestine. Bile can reflux from the small intestine into the stomach and does so normally. However, in a subset of people who have severe GERD (backwashing of acid and bile into the esophagus), including in those who have Barrett's esophagus, there is an increase for back washing into the esophagus. Although acid plays a primary role in the development of Barrett's esophagus, there is evidence that bile, reflux adds to the effect of acid injury to the esophagus and therefore may contribute to the development of Barrett's esophagus and possibly esophageal adenocarcinoma (cancer).

7 Dumping Syndrome Dumping Syndrome (Symptoms of the dumping syndrome include cardiovascular problems with weakness, sweating, nausea, diarrhea and dizziness) can occur in some patients after gastric bypass. This can be so severe that the surgery may have to be reversed or revised. Bowel Obstruction Any abdominal operation can leave behind scar that can put the patient at risk for later bowel blockage or obstruction. The bowel can twist, obstruct and even perforate leading to serious complications and even death. Laparoscopic Surgery Risks Side Effects of Drugs Loss of Bodily Function Risks of Transfusion Hernia Hair Loss Vitamin and Mineral Deficiencies Inadequate Weight Loss Laparoscopic Surgery uses punctures to enter the abdomen and this can to lead to abdominal organ and/or blood vessel injury, bleeding and even death. All drugs have inherent risks and complications and in some cases can cause a wide variety of side effects, reactions and in some cases including death. The performance of surgery and anesthesia can stress the body s systems leading to a variety of complications including nerve damage, stroke, heart attack, limb loss and other problems related to operation and anesthesia. Including Hepatitis and Acquired Immune Deficiency Syndrome (AIDS), from the administration of blood and/or blood components. These illnesses are serious and can be fatal. Cuts and incisions in the abdominal wall can lead to hernias after surgery. Hernias can lead to pain, bowel blockage, obstruction and even perforation and death in some cases. Treatment of hernias usually requires another operation. Many patients develop hair loss for a period after operation. When this occurs it usually starts around 3-4 months after surgery and resolves at 7-9 months after operation. This usually responds to increased oral intake of protein and vitamins but it may be permanent. After gastric bypass there is a malabsorption of many vitamins and minerals. Patients must take vitamin and mineral supplements forever to protect themselves from these problems. I know that I also need to have yearly blood tests to measure the blood levels of these vitamins and minerals. Common deficiencies that can occur after gastric bypass include iron and calcium deficiency, B12, Thiamine and Folate deficiencies. *** I know there is a risk of Wernicke's encephalopathy and other rare nerve and brain damage if I do not carefully follow these instructions. Wernicke's encephalopathy is a severe syndrome characterized by loss of short-term memory. It is linked to brain damage and is the result of inadequate intake or absorption of thiamine (Vitamin B1) coupled with continued carbohydrate ingestion. *** I know that this is very important: Patients must take vitamin and mineral supplements continuously and forever. In some cases the deficiencies are so severe that they can lead to nerve and brain damage and the operation must be reversed. WARNING: Remember that you might not lose weight after the operation. You might gain weight all kinds of problems with my weight after surgery. *There are patients that will fail any type of surgery. Inadequate weight loss is a risk of all types of weight loss surgery and indeed of all types of weight loss treatment.

8 Excessive Weight Loss Complications of Pregnancy Unplanned Pregnancy Other Depression *I recognize that the Mini-Gastric Bypass is not by any means a perfect treatment and that one of the risks that I face is a real possibility of inadequate weight loss following my Mini-Gastric Bypass surgery. I clearly understand that there is a risk that I might suffer malnutrition and lose too much weight. I am well aware that some patients sustain excessive weight loss after weight loss operations. I understand that excessive weight loss may require surgical revision or reversal of the bypass to prevent severe malnutrition, nausea or vitamin and mineral deficiencies or even death. I understand that almost 1% of patients lose too much weight following weight loss surgery and need to have surgery to reverse the excessive weight loss. As part of this agreement, I promise and agree to monitor my weight and health carefully and if excessive weight loss occurs, I will submit to early and appropriate treatment. I hereby formally and unequivocally state that I am prepared for this possibility of malnutrition and/or excessive weight loss and can afford to see Dr. Rutledge/Dr. Billy, my surgeon or someone else and can pay for and receive the appropriate surgical treatment of a revision if necessary. I understand that obese pregnant women are at high risk for adverse perinatal outcome. I am also aware that there are well known risks to the patient and the baby after surgery for morbid obesity. Vitamin and mineral deficiencies can put the newborn babies of gastric bypass mothers at risk. No pregnancy should occur for the first one to two years after operation. Gastric Bypass has been shown to cause multiple types of vitamin and mineral deficiencies including: iron, B12, Folate, Thiamine, calcium and many others. Many of these deficiencies have been shown to cause birth defects or are suspected that they could cause birth defects. We also know that many patients who lose weight feel that they are well after surgery and forget to take their vitamins. I understand and take full responsibility to be certain not to miss any of my vitamins and obtain obstetric consultation if I decide to go ahead with pregnancy following surgery. I understand all of these risks fully and request that Dr. Rutledge/Dr. Billy proceed with surgery. Warning to women using Oral Contraceptives (Birth Control Pills): More than 80 million women worldwide take "the pill" to prevent pregnancy. Typical failure rates among pill users are as high as 12% to 20% in some surveys. Other factors have been shown to increase the risk of pill failure: smoking, diarrhea and/or vomiting drug interactions, systemic illness, psychological stress, and menstrual disturbances. Therefore, it is important to recognize that Birth Control Pills may not be an effective method of birth control after the Mini-Gastric Bypass until those factors have resolved. We have found on several occasions that in many cases the hormonal methods of birth control fail after Mini-Gastric Bypass. Couples need to plan another form of non-hormonal birth control for 6-12 months after surgery. Depo-Provera has also been associated with marked cases of nausea in post MGB patients. An unplanned pregnancy can be one of life's most difficult experiences. Major abdominal surgery, including the Mini-Gastric Bypass, is associated with a large variety of other risks and complications, both recognized and unrecognized that occur both soon after and long after the operation. Depression and anxiety are common medical illnesses and have been found to be particularly common after weight loss operations.

9 Osteoporosis Cancer Death There is growing appreciation that weight loss procedures may be associated with the development of osteoporosis and bone disease. Osteomalacia (soft bones) and secondary hyperparathyroidism can occur in obese individuals who have not undergone any kind of gastric surgery. There is a long-standing recognition of a relationship between gastrointestinal surgery and the development of bone diseases (osteomalacia, osteitis fibrosa cystica, and osteoporosis.) In a study patients who had undergone Roux-Y gastric bypass had lost 8% of Bone Mass Density 9 months. Similar results were found in other studies. Gastric surgery and weight loss in morbidly obese individuals cause increased bone resorption and increased bone loss. Treatment and prevention includes calcium and vitamin D supplementation and increased physical activity Cancer can occur in anyone. Many cancers are more common in obese as compared to thin patients. Overweight men have a significantly higher rate of prostate cancer. Obese women have higher risks of developing breast cancer and cancer of the uterus and ovaries. It is expected, but not certain, that with weight loss you will have an overall decrease in your risk of cancer. The Billroth II connection used in the Mini-Gastric Bypass has been used for almost 100 years and is performed over 16,000 times a year in America to connect the stomach to the bowel. Some studies have suggested that the Billroth II connection used in the Mini-Gastric Bypass can increase the risk of stomach cancer while others do not show this. The studies showing increase risk of stomach cancer are in Billroth II patients that had the surgery for ulcers and since ulcers can cause an increased risk of stomach cancer it may be the stomach ulcer not the Billroth II that causes some studies to show increased risk of stomach cancer after the Billroth II. Diet seems to be much more important as a cause of stomach cancer. Eating processed meats has a much greater effect on increasing stomach cancer risk that the Billroth II. Conversely fresh fruits and vegetables seem to protect against stomach cancer. In the end no one knows what will happen in your case and if you are concerned about stomach cancer then you could either 1) Not have the Mini-Gastric Bypass, 2) Have the Mini-Gastric Bypass and avoid processed meats and eat more fresh fruits and vegetables. In either case stomach cancer is an unlikely event. This is a major and serious operation. It may lead to death from complications. There has been a death in the first week after this surgery in one patient. If you agree that everything in the above paragraphs is correct, check Yes Write a Description of the Previous Paragraphs and Comments (More than 2 sentences): Excessive Weight Loss I clearly understand that there is a risk that I might suffer malnutrition and lose too much weight. I know that the diagnosis of excess weight loss is easy. I have excess weight loss if I do not feel well if my yearly blood tests that I have agreed to show any forms of low values, abnormal values or deficiencies. If I feel fatigue, weakness, if my friends or family or physician or acquaintances, comment on my weight or appearance. At that moment I know that should, and by this agreement I hereby confirm, that I will arrange to see Dr. Rutledge, Dr Billy or other physician to confirm the presence of excess weight loss,

10 deficiency or malnutrition. I know now and agree that the Mini-Gastric Bypass can be easily reversed by Dr. Rutledge\Dr. Billy and that I stand ready and able to deal with this possibility by returning to see Dr. Rutledge/Dr. Billy in his clinic and having the surgery revised reversed if necessary. Furthermore I now state that if I do not act in this clear and responsible manner that I cannot hold Dr. Rutledge or Dr. Billy responsible for any outcome. I fully agree that Dr. Rutledge\Dr. Billy cannot be held responsible for problems, bad outcomes or poor results if I do not follow reasonable care by returning for revision if needed. If I do not return to to undergo treatment than I agree I have broken the doctor patient relationship. It is clear to me and my family that the the MGB bypass is powerful therapy, and that the bypass can cause the patient to lose too much weight. Excess weight loss if not treated can lead to severe complications and death. I also know that the excess weight loss from the Mini-Gastric Bypass can be easily reversed by a short operation. I am well aware that some patients sustain excessive weight loss after weight loss operations. I understand that excessive weight loss may require surgical revision or reversal of the bypass to prevent severe malnutrition, nausea or vitamin and mineral deficiencies or even death. I understand that almost 1% of patients lose too much weight following weight loss surgery and need to have surgery to reverse the excessive weight loss. As part of this agreement, I promise and agree to monitor my weight and health carefully and if excessive weight loss occurs, I will submit to early and appropriate treatment. I hereby formally and unequivocally state that I am prepared for this possibility of malnutrition and excessive weight loss and can afford to see Dr. Rutledge\Dr. Billy and CaCLOS to pay for and receive the appropriate surgical treatment of a revision if necessary. I understand that excess weight loss on my part that does not lead to immediate return to clinic to see Dr. Rutledge\Billy for urgent therapy constitutes a breach of the doctor patient relationship. That is to say if I do not take care of myself then clearly Dr. Rutledge\Billy cannot be held responsible for any bad outcomes. Again in plain words: I know I can have excess weight loss, malnutrition and deficiencies from an operation designed to cause weight loss. A weight loss surgery can only have three outcomes; perfect weight loss, inadequate weight loss and excess weight loss. I am very well educated that I might lose too much weight and that I can easily have this issue of excess weight loss treated by revising the surgery. I know that I, the patient must take the responsibility of identifying the excess weight loss and seeking appropriate follow up with Dr. Rutledge/Dr. Billy. That responsibility is one I fully and completely accept. In the event that I fail to return to Dr. Rutledge/Dr. Billy for treatment I here by now and forever agree to hold Dr. Rutledge/Dr. Billy blameless for any and all problems complications and even death that can occur from my irresponsible act. I know if I get too thin it can be fixed. I agree if I get too thin to come to Dr. Rutledge/Dr. Billy to get the problem fixed. If I do not come to get the problem fixed then that is completely my personal responsibility. I understand and expect that the costs of surgery to reverse or revise surgery will be roughly the same as the initial surgery. Risks and Complications from General Anesthesia Serious side effects of general anesthesia are well known to occur but fortunately are uncommon. This is not true in people who are unhealthy including people that are obese. Because general anesthesia affects the whole body, it is more likely to cause side effects than local or regional anesthesia. Fortunately, most side effects of general anesthesia are uncommon, minor and can be easily managed. But others can be serious or deadly. General anesthesia suppresses the normal throat reflexes such as swallowing, coughing, or gagging that prevent aspiration. Aspiration occurs when materials, objects or liquids are inhaled into the respiratory tract (the windpipe or the lungs). To help prevent aspiration, an endotracheal (ET), breathing tube will be inserted during the surgery this is called general anesthesia. When an ET tube is in place, the lungs should be protected so stomach contents cannot enter the lungs. Aspiration during anesthesia and surgery is uncommon, but does occur and is a risk of surgery especially in overweight or obese patients. You have been instructed not to eat or drink anything for hours before anesthesia so that the stomach is empty to reduce the risk of aspiration. Anesthesia specialists use many safety measures to minimize the risk of aspiration in all patients but in spite of

11 these measures aspiration and serious or deadly pneumonia can occur. Insertion or removal of airway tubes for general anesthesia can cause respiratory problems such as coughing; gagging; muscle spasms in the voice box, or larynx (laryngospasm); or bronchial tubes in the lungs (bronchospasm). Insertion of airways also may cause an increase in blood pressure (hypertension) and heart rate (tachycardia). Other complications may include damage to teeth and lips, swelling in the larynx, sore throat, and hoarseness caused by injury or irritation of the larynx. Other serious risks of general anesthesia include changes in blood pressure or heart rate or rhythm, heart attack, or stroke. Death or serious illness or injury due to anesthesia is rare and is usually also related to complications from the surgery. Death has been reported to occur in about 1 in 250,000 people receiving general anesthesia, although risks are greater for those people with obesity and other medical conditions. Many people who are going to have general anesthesia express concern that they will not be completely unconscious but will "wake up" and have some awareness during the surgical procedure. However, awareness during general anesthesia is uncommon but can happen. By agreeing to surgery and anesthesia in this document you are recognizing that while precautions will be taken to avoid awareness during surgery that it could happen. To decrease the serious and life threatening risks of anesthesia that lead to death Dr. Rutledge/Dr. Billy and the physicians and surgeons of the California Center for Laparoscopic Obesity Surgery have chosen a very special kind of anesthetic technique that they believe improve your chances of safely recovering from surgery but may increase the chance of awareness during surgery. By your initials and comments below you agree to proceed with surgery and anesthesia with the full knowledge of the risk of awareness under this anesthesia and by your specific request that this form of anesthesia be used to improve your overall chances of safety. Initial the paragraphs above Risks and Complications from General Anesthesia: Awareness during General Anesthesia A person who is given general anesthesia but is not unconscious may be aware of what is happening during the procedure. Awareness during actual surgery is rare but can happen. The frequency of anesthesia awareness has been found in multiple studies to range between 0.1% - 0.2% of adult patients undergoing general anesthesia. Awareness may be recalled as an implicit memory or explicit memory. With implicit memory, information is retained but not consciously recalled. The person may display symptoms similar to post-traumatic stress disorder, including dreams, flashbacks, anxiety, and sleep disturbances. With explicit memory, the person has spontaneous recall of events that occurred during the procedure, such as sounds and sensations of paralysis or pain. Consultation with a psychiatrist or psychologist may be warranted if a person has signs or symptoms of psychological trauma from awareness during surgery. By your initials and statements below you agree that you are aware of these risks and complications and specifically request that with full knowledge that these potential problems and complications could occur that we proceed with surgery. Initial the paragraphs above The use of Total Intravenous Anesthesia (TIVA), For the purpose of improving safety and avoiding respiratory complications of anesthesia Dr. Rutledge/Dr. Billy and the

12 physicians and surgeons of CaCLOS advocate the use of total intravenous anesthesia (TIVA). TIVA stands for Total Intravenous Anesthesia: all the medications you receive will be administered through an IV catheter and you will not receive anesthetic gas. Gas anesthetics, while often good choices, are deemed more dangerous than TIVA in your case. To try to avoid awareness during surgery Dr. Rutledge/Dr. Billy and the physicians and surgeons of CaCLOS follow the Practice Advisory Guidance to Clinicians from the American Society of Anesthesiologists: The practice advisory acknowledges the reported incidence of intraoperative awareness of one to two cases per thousand patients receiving general anesthesia. We also recognize the significant psychological harm that some patients may experience following an episode of awareness. To address this safety concern Dr. Rutledge/Dr. Billy and the physicians and surgeons of CaCLOS treat all patients as high risk for awareness, you are now informed that your anesthetic depth will be monitored using multiple modalities. In all of Dr. Rutledge/Dr. Billy and the physicians and surgeons of CaCLOS patients brain function monitoring is used on all patients undergoing general anesthesia (BIS Monitoring.) The majority of ASA members (69%) surveyed believes that brain function monitoring (BIS monitoring) is valuable and should be used to help reduce the incidence of awareness in patients at risk. If you sustain awareness you agree to inform us so that we can provide assessment, reporting and counseling. Dr. Rutledge/Dr. Billy and the physicians and surgeons of CaCLOS believe that all MGB patients are at risk for intraoperative awareness. Risk factors for awareness include: * Substance use or abuse; * Patient history of awareness; * Difficult intubation; * Cardiac surgery, Cesarean section, trauma and emergency surgery; * Reduced anesthetic doses in the presence of paralysis; * Use of muscle relaxants; and * Total intravenous anesthesia (TIVA) and other anesthesia techniques. Clinical Evidence Supporting BIS Monitoring Brain Function Monitoring Brain function monitors enable the anesthesia provider to measure the level of consciousness based upon the patient's electroencephalogram (EEG). Adjunctive use of bran functioning monitors during anesthesia has been found to reduce awareness. The ASA practice advisory provides documentation that BIS monitoring is the only brain monitoring technology or clinical intervention that has been shown in large scale, prospective clinical research to reduce the incidence of awareness. In summary, you will receive TIVA because Dr. Rutledge/Dr. Billy and the physicians and surgeons of CaCLOS believe it is the safest choice. You have a risk of awareness during surgery (about 1-2/1,000.) The BIS electronic brain monitoring system will be used to help protect against awareness. Addition of Ketamine for the Prevention of Post-Operative Pain In spite the availability of effective analgesic agents, between 30 to 70% of patients continue to suffer severe postoperative pain. A variety of causes of inadequate control of post-operative pain have been identified.

13 Our goal is the delivery of the best possible pain relief for your post-operative recovery. That means our desire is expend our efforts to try to deliver a balance of safety and effectiveness in post-operative pain management. Opioids Intravenous, intramuscular, and oral as needed (prn), opioid (narcotic) analgesia (pain medication) is the most commonly used method of postoperative pain management. While narcotics are very effective pain relievers they are also well known as dangerous and sometimes deadly drugs. Narcotics can cause breathing to slow or even stop and especially in obese patients this risk is magnified. Thus our desire is to take away all of our patients pain but the risks of narcotics keep us ever mindful of their potential to harm as well as help our patients. Recently a new use of an old drug (ketamine) has been shown to decrease patient s post-operative pain and to decrease the need for the use of narcotics increasing patient safety. The following section is designed to explain more about the use of ketamine for your post-operative pain management. Ketamine Ketamine is a rapid-acting general anesthetic normal or slightly enhanced skeletal muscle tone, cardiovascular and respiratory stimulation, and occasionally a transient and minimal respiratory depression. The patient s airway is well maintained. Ketamine has a wide margin of safety; several instances of unintentional administration of overdoses of Ketamine (up to ten times that usually required) have been followed by prolonged but complete recovery. Ketamine has been studied in over 12,000 operative and diagnostic procedures, involving over 10,000 patients from 105 separate studies. During the course of these studies, Ketamine was administered as the sole agent, as induction for other general agents, or to supplement low-potency agents. Ketamine has been used successfully in many types of surgery including the anesthesia for a variety of other surgical procedures. In these studies, the anesthesia was rated either excellent or good by the anesthesiologist and the surgeon at 90% and 93%, respectively Warnings Postoperative confusional states may occur during the recovery period. Respiratory depression may occur with over dosage or too rapid a rate of administration of Ketamine, in which case supportive ventilation should be employed. Precautions Information for Patients: The patients should be cautioned that driving an automobile, operating hazardous machinery or engaging in hazardous activities should not be undertaken for 24 hours or more (depending upon the dosage of Ketamine and consideration of other drugs employed) after anesthesia. Drug Interactions: Prolonged recovery time may occur if barbiturates and/or narcotics are used concurrently with Ketamine. Ketamine is clinically compatible with the commonly used general and local anesthetic agents. Usage in Pregnancy: Since the safe use in pregnancy, including obstetrics (either vaginal or abdominal delivery), has not been established, such use is not recommended. Adverse Reactions Emergence reactions have occurred in approximately 12 percent of patients. The psychological manifestations vary in severity between pleasant dream-like states, vivid imagery, hallucinations, and emergence delirium. In some cases these states have been accompanied by confusion, excitement, and irrational behavior which a few patients recall as an unpleasant experience. The duration ordinarily is no more than a few hours; in a few cases, however, recurrences have taken place up to 24 hours postoperatively. No residual psychological effects are known to have resulted from use of ketamine. The incidence of these emergence phenomena is least in the elderly (over 65 years of age) patient. Also, they are less frequent when the drug is given intramuscularly and the incidence is reduced as experience with the drug is gained. The incidence of psychological manifestations during emergence, particularly dream-like observations and emergence delirium, may be reduced by using lower recommended dosages of ketamine in conjunction with intravenous diazepam during induction and maintenance of anesthesia. Also, these reactions may be reduced if verbal, tactile and visual stimulation of the patient is minimized during the recovery period. This does not preclude the monitoring of vital signs. In order to terminate a severe emergence reaction the use of a small hypnotic dose of a short-acting or ultra-short-acting barbiturate may be required. When ketamine is used on an outpatient basis, the patient should not be released until recovery from anesthesia is complete and then should be accompanied by a responsible adult. Cardiovascular: Blood pressure and pulse rate are frequently elevated following administration of Ketamine alone. However, hypotension and bradycardia have been observed. Arrhythmia has also occurred. Respiration: Although respiration is frequently stimulated, severe depression of respiration or apnea may occur following rapid

14 intravenous administration of high doses of Ketamine. Laryngospasms and other forms of airway obstruction have occurred during Ketamine anesthesia. Eye: Diplopia and nystagmus have been noted following Ketamine administration. It also may cause a slight elevation in intraocular pressure measurement. Neurological: In some patients, enhanced skeletal muscle tone may be manifested by tonic and clonic movements sometimes resembling seizures. Gastrointestinal: Anorexia, nausea and vomiting have been observed; however, this is not usually severe and allows the great majority of patients to take liquids by mouth shortly after regaining consciousness. General: Anaphylaxis: Local pain and exanthema at the injection site have infrequently been reported. Transient erythema and/or morbilliform rash have also been reported. Low dose Ketamine is now being used in cases to supplement anesthesia, support the blood pressure and improve pain relief and decrease the need for narcotics, thus making the recovery safer and less painful. Excessive Weight Loss after Surgery I clearly understand that there is a risk that I might lose too much weight. I am well aware that some patients sustain excessive weight loss after weight loss operations. I understand that excessive weight loss may require surgical revision or reversal of the bypass to prevent severe malnutrition, nausea or vitamin and mineral deficiencies or even death. I understand that in the CaCLOS experience almost 1 out of every 100 patients lose too much weight following weight loss surgery and need to have surgery to reverse the excessive weight loss. As part of this agreement, I promise and agree to monitor my weight and health carefully and if excessive weight loss occurs, I will submit to early and appropriate treatment. I hereby formally and unequivocally state that I am prepared for this possibility of excessive weight loss and can afford to see Dr. Rutledge/Dr. Billy and CaCLOS to pay for and receive the appropriate surgical treatment of a revision if necessary. I understand and expect that the costs of surgery to reverse or revise surgery will be roughly the same as the initial surgery. Special Warning about the Risks of Birth Defects after Gastric Bypass: Vitamin and mineral deficiencies can put the newborn babies of gastric bypass mothers at special risk of Major Birth Defects. No pregnancy should occur for the first one to two years after operation. Gastric Bypass has been shown to cause multiple types of vitamin and mineral deficiencies including: iron, B12, Folate, calcium and many others. Many of these deficiencies have been shown to cause birth defects or are suspected that they could cause birth defects. We also know that many patients who lose weight feel that they are well after surgery and forget to take their vitamins. Patients must be certain not to miss any of their vitamins if they decide to go ahead with pregnancy later. Warning to women using Oral Contraceptives (Birth Control Pills): Many women take 'the pill' to prevent pregnancy. Typical failure rates among pill users are as high as 12% to 20% in some surveys. Other factors have been shown to increase the risk of pill failure: smoking, diarrhea and/or vomiting drug interactions, systemic illness, psychological stress, and menstrual disturbances. Therefore BC Pills may not be an effective method after the Mini-Gastric Bypass until those factors have resolved. An unplanned pregnancy can be one of life's most difficult experiences.